FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression

Conditions

• Interstitial Lung Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nerandomilast — DRUG
  Nerandomilast
• Placebo matching nerandomilast — DRUG
  Placebo matching nerandomilast

Study Details

This study is open to adults with fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF). People can join the study if they have been diagnosed with this condition within the last 3 years and are at risk of developing progressive pulmonary fibrosis (PPF). The purpose of this study is to find out whether a medicine called nerandomilast helps people with fibrosing interstitial lung disease who may be at risk for their disease getting worse. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Nerandomilast is a type of medicine that may help reduce lung function decline and slow disease progression. Participants are in the study for up to about 2 years and 4 months. During this time, they visit the study site regularly. Doctors regularly test lung function using methods like spirometry to measure forced vital capacity (FVC, maximum amount of air a participant can blow out after taking a deep breath) and DLCO (diffusing capacity of the lungs for carbon monoxide; it estimates how well oxygen moves from the lungs into the blood). Additionally, high-resolution computed tomography (HRCT) is performed to monitor how the lung condition is changing over time. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Key Dates

Start date

Aug 28, 2026

Status verified

Jun 2026

Primary completion

Dec 5, 2028

Completion

Dec 12, 2028

Study Design

Enrollment

466 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nerandomilast arm
• Placebo Comparator: Placebo arm

Primary Outcome Measure

Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52 [ Time Frame: at baseline, at week 52 ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (18)

Find similar trials in Birmingham, AL

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